Nite time Severe Cold and Flu

Product NDC: 41250-877
11-digit product format: 412500877
Labeler code: 41250
Product ID: 41250-877_908a3106-2529-4252-a766-14b53d39ac84
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Meijer Distribution Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-08-01
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Nite time Severe Cold and Flu
Brand name suffix: Maximum Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
DOXYLAMINE SUCCINATE	6.25 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1546881	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41250-877-08	Nite time Severe Cold and FluMaximum Strength	2 in 1 CARTON	TABLET, FILM COATED	2		16
41250-877-08	Nite time Severe Cold and FluMaximum Strength	12 in 1 BLISTER PACK	TABLET, FILM COATED	12		16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-877	NITE TIME SEVERE COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	15	Current NDC, Legacy NDC, 2 package rows	20250126_f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 142 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good neighbor pharmacy adult tussin DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	ced71993-f535-4e28-bc1d-3fcb7d86e9b7	2024-11-08	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS Pharmacy	2f1dc8f8-79c5-4724-99aa-a55330ed9d5f	2024-11-08	Warnings	Exact identifier application number: M012
good sense day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	4ac6b64a-8214-4b03-8aa5-0d3199cf0b72	2024-11-08	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	1dd9afb6-9b58-4274-a557-900a0cb23524	2024-11-08	Warnings	Exact identifier application number: M012
DG health sinus severe	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	7abaa912-be8b-463c-8818-104e79b33539	2024-11-07	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Cold Plus Flu Multi-Action Day	ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	7d3266dc-879a-4d28-b8ea-74d238c3020a	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	2ddb86a8-e34c-4a03-a60a-d3fedaf90608	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ce43e5c2-fe96-4462-882c-d7479318b33d	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL SINUS PLUS HEADACHE DAY	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e608d214-cc46-4a24-ac85-1040e36e7403	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	e83f7911-22b4-4ffc-8f49-68f6acd2ebf5	2024-11-07	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.	Kenvue Brands LLC	f81d924e-10e9-0e9d-e053-6294a90a2ddf	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	8b516736-86ac-47cb-a0ec-038d4c3a0020	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu plus Cough Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e85e5eb9-3ecf-4784-999e-111e38e306f5	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ef8a846d-4b29-4fd8-a683-fada04d0a2b9	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	9761c807-75a1-4498-a8c6-1f2b1c9ffde6	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Mucus Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	24ac94e8-b223-424e-bcd2-9c027c8ff9ed	2024-11-07	Warnings	Exact identifier application number: M012
Primatene	EPHEDRINE HYDROCHLORIDE	Foundation Consumer Brands	2170f081-c03f-47e8-bc63-4052c5e653fa	2024-11-07	Warnings	Exact identifier application number: M012
Rompe Pecho Max Multi Symptoms	ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN	EFFICIENT LABORATORIES INC	938e4e47-d2d9-4b0d-bf88-e9f41b501945	2024-11-07	Warnings	Exact identifier application number: M012
topcare sinus nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	ca1fefed-e9d7-430a-9da4-972b1a6fb786	2024-11-07	Warnings	Exact identifier application number: M012
Leader Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	dd82a389-9ec5-4b3f-a9ea-1a56871ebd17	2024-11-07	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1546881	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13	16
1546881	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13	16
1546881	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-877-08	41250087708	2 BLISTER PACK in 1 CARTON (41250-877-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2015-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer 44-677	Meijer Distribution Inc \| LNK International, Inc.	2026-07-02	HUMAN OTC DRUG LABEL	17